{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "country": "United States",
      "city": "Branchburg",
      "address_1": "1080 Us Highway 202 S",
      "reason_for_recall": "Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the  cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media kits.",
      "address_2": "",
      "product_quantity": "84 kit batches",
      "code_info": "K110923    cobas PCR Female Swab Sample Kit  05170516190  Lot S01487 and earlier    cobas PCR Urine Sample Kit  05170486190  Lot S01885 and earlier  (except lot number S01884)    IVD: 48 kit batches  US: 31 kit batches  JPN-IVD:6 kit batches",
      "center_classification_date": "20140226",
      "distribution_pattern": "Nationwide Distribution",
      "state": "NJ",
      "product_description": "cobas¿ PCR Urine Kit 100 PKT IVD  cobas¿ PCR Female Swab Kit 100 PKT IVD  cobas¿ PCR media 100T IVD  cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD    Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA     Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457    The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.",
      "report_date": "20140305",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "recall_number": "Z-1111-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67441",
      "termination_date": "20140807",
      "more_code_info": "",
      "recall_initiation_date": "20140106",
      "postal_code": "08876-3733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}